Peri-implant Disease Perception Before and After Non-Surgical Peri-implant Therapy

NCT ID: NCT06901388

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-07-29

Brief Summary

The present pre-post quasi-experimental study assessed changes in peri-implant disease perception and oral health-related quality of life following non-surgical peri-implant therapy. Using validated psychometric tools, including the Brief Illness Perception Questionnaire (Brief-IPQ) and the Oral Health Impact Profile-14 (OHIP-14), the study evaluates patients at baseline and three months after therapy. The study builds upon prior cross-sectional findings highlighting the low perception of peri-implant diseases and aims to determine whether non-surgical treatment improves patients' psychological awareness and perceived impact of their condition.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single group

All participants will receive non-surgical peri-implant therapy consisting of mechanical debridement and oral hygiene instruction. Psychometric assessments (Brief-IPQ and OHIP-14) will be administered at baseline and 3 months after treatment to evaluate changes in illness perception and oral health-related quality of life.

Group Type: EXPERIMENTAL

Non-surgical peri-implant therapy

Intervention Type: PROCEDURE

Standardized non-surgical therapy consisting of mechanical debridement of peri-implant sites using ultrasonic instruments, combined with personalized oral hygiene instruction. The intervention is delivered in a single session. No adjunctive antimicrobials are used. Follow-up is scheduled 3 months after therapy for clinical and psychometric re-evaluation.

Interventions

Non-surgical peri-implant therapy

Standardized non-surgical therapy consisting of mechanical debridement of peri-implant sites using ultrasonic instruments, combined with personalized oral hygiene instruction. The intervention is delivered in a single session. No adjunctive antimicrobials are used. Follow-up is scheduled 3 months after therapy for clinical and psychometric re-evaluation.

Intervention Type: PROCEDURE

Other Intervention Names

Mechanical debridement + Oral hygiene instruction

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 80 years
• Diagnosis of peri-implant disease requiring non-surgical therapy
• Presence of at least one dental implant loaded for a minimum of one year
• History of periodontitis
• Good general health
• Ability to provide written informed consen

Exclusion Criteria

• Pregnant or lactating individuals
• Inability to perform basic oral hygiene procedures
• Inability to understand or complete study questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOUS

Siena, , Italy

Countries

Italy

Other Identifiers

BIPP001

Identifier Type: -

Identifier Source: org_study_id